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The primary purpose of the study is to evaluate the effects of mild and moderate hepatic impairment on PK of tasurgratinib after a single dose administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Mild Hepatic Impairment (Child Pugh Class A) | Experimental | Participants with mild hepatic impairment will receive a single 35 milligram (mg) tablet of tasurgratinib in the morning with 150 milliliters (mL) of water following an overnight fast of at least 10 hours. |
|
| Cohort B: Moderate Hepatic Impairment (Child Pugh Class B) | Experimental | Participants with moderate hepatic impairment will receive 10 mg dose of tasurgratinib as capsule (2 capsules each of 5 mg) in the morning with 150 mL of water following an overnight fast of at least 10 hours. |
|
| Cohort C: Healthy Participants (Control) | Experimental | Healthy participants matched to participants with hepatic impairment in Cohorts A and B (matched with regards to age, race, gender and body weight) will receive a single 35 mg tablet of tasurgratinib in the morning with 150 mL of water following an overnight fast of at least 10 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tasurgratinib | Drug | Tasurgratinib oral tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration of Tasurgratinib | Day 1: 0-144 hours postdose | |
| AUC(0-t): Area Under the Plasma Concentration versus Time Curve from Time 0 to Time of Last Quantifiable Concentration of Tasurgratinib | Day 1: 0-144 hours postdose | |
| AUC(0-inf): Area Under the Plasma Concentration versus Time Curve from Time 0 to Infinity of Tasurgratinib | Day 1: 0-144 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax: Time to Reach Maximum Plasma Concentration of Tasurgratinib and its Metabolite | Day 1: 0-144 hours postdose | |
| AUC(0-72Hours): Area Under the Plasma Concentration versus Time Curve from Time 0 to 72 Hours of Tasurgratinib and its Metabolite | Day 1: 0-144 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
Key Exclusion for all Participants:
Following ocular disorders
Known to be human immunodeficiency virus (HIV) positive at Screening.
A prolonged QT/QTc interval ([QT interval using Fridericia's formula] QTcF greater than (>) 480 millisecond [ms]) demonstrated on ECG.
Additional Exclusion Criteria for Hepatically Impaired Participants (Cohorts A and B)
In addition to the Exclusion Criteria above for all participants, other standard exclusion criteria for participants with hepatic impairment will be used. These include:
Additional Exclusion Criteria for Healthy participants (Cohort C)
In addition to the Exclusion Criteria for all participants, other standard exclusion criteria for healthy participants in Phase 1 studies will be used. These include:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Inquiry Service. | Contact | eisai-chiken_hotline@hhc.eisai.co.jp |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eisai Trial Site #6 | Recruiting | Hakata | Fukuoka | Japan | ||
| Eisai Trial Site #4 |
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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| Tasurgratinib | Drug | Tasurgratinib oral capsule. |
|
| T1/2: Terminal Phase Plasma Half-life of Tasurgratinib and its Metabolite | Day 1: 0-144 hours postdose |
| CL/F: Apparent Total Body Clearance of Tasurgratinib | Day 1: 0-144 hours postdose |
| Vz/F : Apparent Volume of Distribution at Terminal Phase of Tasurgratinib | Day 1: 0-144 hours postdose |
| AUC Metabolite Ratio: Ratio of AUC(0-inf) of M2 to AUC(0-inf) of Tasurgratinib, Corrected for Molecular Weights | Day 1: 0-144 hours postdose |
| fu: Plasma Protein Unbound Fraction of Tasurgratiniband its Metabolite | Day 1: 0-144 hours postdose |
| AUCu: AUC(0-inf) Values Adjusted by Unbound Fraction in Plasma of Tasurgratinib | Day 1: 0-144 hours postdose |
| CLu/F: Apparent Clearance Relative to the Unbound Plasma Concentration of Based on AUCu of Tasurgratinib | Day 1: 0-144 hours postdose |
| Terminated |
| Kurume |
| Fukuoka |
| Japan |
| Eisai Trial Site #2 | Recruiting | Yuhu | Oita Prefecture | Japan |
| Eisai Trial Site #3 | Recruiting | Bukyo-ku | Tokyo | Japan |
| Eisai Trial Site #1 | Recruiting | Mintato-ku | Tokyo | Japan |
| Eisai Trial Site #8 | Recruiting | Shinjuku-ku | Tokyo | Japan |
| Eisai Trial Site #5 | Recruiting | Kofu | Yamanashi | Japan |
| Eisai Trial Site #7 | Recruiting | Kyoto | Japan |